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FDA 510(k)

ENABLER-P CATHETER, 1000 PART NUMBER:1160

K-Number: K083833 · 2009-05-22

ApplicantEndocross, Ltd.
Decision Date2009-05-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENABLER-P CATHETER, 1000 PART NUMBER:1160 is the device name listed in this FDA 510(k) record. The listed applicant is Endocross, Ltd.. It received FDA 510(k) clearance on 2009-05-22 under 510(k) number K083833. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENABLER-P CATHETER, 1000 PART NUMBER:1160?

ENABLER-P CATHETER, 1000 PART NUMBER:1160 is a medical device that received FDA 510(k) clearance on 2009-05-22. The listed applicant is Endocross, Ltd.. The 510(k) number is K083833.

When did ENABLER-P CATHETER, 1000 PART NUMBER:1160 receive FDA 510(k) clearance?

ENABLER-P CATHETER, 1000 PART NUMBER:1160 received FDA 510(k) clearance on 2009-05-22, under 510(k) number K083833.

Who is the listed applicant for ENABLER-P CATHETER, 1000 PART NUMBER:1160?

The FDA 510(k) record lists Endocross, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENABLER-P CATHETER, 1000 PART NUMBER:1160?

The FDA product code for ENABLER-P CATHETER, 1000 PART NUMBER:1160 is DQY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Endocross, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092174ENABLER-P CATHETER SYSTEM, MODEL 3000K082339ENABLER-P SUPPORT CATHETER

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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